Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea

Evaluation of Efficacy of Botulinum Toxin Type A in the Treatment of Sialorrhea in the Patient Affected by Amyotrophic Lateral Sclerosis (ALS)

Evaluation of the decrease of the secretion of saliva in patients with amyotrophic lateral sclerosis by a local ultrasound-guided bilateral injection of botulinum toxin type A in parotids and submandibular glands. The investigators want to demonstrate 1 month after the injection, by a multicenter French randomized double blind study, an improvement of at least 25 % of the functional embarrassment due to saliva, estimated with a visual analogue scale, a decrease of the quantity of saliva and a decrease of the embarrassment for the main caregiver.

The patient will benefit from an ultrasound guided injection of botulinum toxin A (Botox®) or placebo (NaCl 0.9 %) and will be followed up in consultation at 4, 12, 16 (if reinjection) and 24 weeks. He will be contacted by telephone in 2 and in 8 weeks (percentage of decrease of functional embarrassment, percentage of decrease of salivary secretion rate). He can be able to benefit in the open label phase of a botulinum toxin type A injection at the 12-week follow up if he estimates that first injection was not effective or if the efficiency of the first injection began to become blurred. After the 6 months of the study, the patient will benefit again from the usual follow-up as advised by the French consensus conference in November, 2005.

Inclusion Criteria:

• Age > 18 years
• Obtaining of a written consent after information
• Diagnosis of probable or certain ALS according to the El Escorial criteria of the World Federation and Neurology Committee on Neuromuscular Diseases
• Patient having a follow-up in an ALS center
• Sialorrhea with VAS functional embarrassment > or equal at 50/100.
• Patient beneficiary of Social Security regime

Exclusion Criteria:

• Evolving disease associated with predictable survival < 1 month
• Patient having previously received an injection of botulinum toxin in the salivary glands
• Patient taking the other medical treatments for sialorrhea in the 7 days before the inclusion in the study (scopoderm, trihexyph'nidyle, atropine, ipatropium, amitriptyline, clomipramine, oxybutinine, diphenhydramine, beta-blockers)
• Patient having benefited from radiotherapy or from surgery on the salivary glands
• Behavioral problems, dementia or other psychiatric problems
• Myasthenia
• Known Pregnancy or absence of contraception recognized as effective, breast feeding